Pulmonary vascular disease & thromboembolismRandomised controlled trial
Ultrasound-Facilitated, Catheter-Directed Fibrinolysis for Acute Pulmonary Embolism
- Randomised controlled trial
- multinational
- adaptive design
- blinded outcome adjudication
Authors' conclusion
In patients with acute, intermediate-risk pulmonary embolism, ultrasound-facilitated, catheter-directed fibrinolysis plus anticoagulation led to a lower risk of the composite of pulmonary embolism-related death, cardiopulmonary decompensation or collapse, or symptomatic recurrence of pulmonary embolism within 7 days than anticoagulation alone.
Study context
- Population
- Acute intermediate-risk PE (RV/LV end-diastolic diameter ratio ≥1.0, elevated troponin) with ≥2 indicators of cardiorespiratory distressITT population
- Participants
- 544 participants
- Comparison
- Intervention vs Control
- Interventionn = 273
- Controln = 271reference
- Primary endpoint
- Composite of:
- PE-related death
- Cardiorespiratory decompensation or collapse
- Symptomatic recurrent PE
- Follow-up
- Within 7 days
Primary result
As reported in the abstract
Relative risk
0.39
95% CI 0.20–0.77
P = 0.005
Events by treatment group
Safety
Major bleeding · within 7 days after randomization
P = 0.32
Major bleeding · within 30 days
P = 0.64
Other serious adverse events; intracranial hemorrhage · up to 30 days after randomization
- No substantial between-group differences in other serious adverse events
- No intracranial hemorrhage occurred
Original publication
Summarised from the published abstract; every number is checked against it